Intravascular ULTrasound Guided Versus Conventional Angiography Guided Strategy to Deploy Zotarolimus and Everolimus Eluting Third Generation Stents in the Long Coronary Artery Lesions: ULTRA-ZET Trial

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion; Procedure: Angiography guided percutaneous coronary angioplasty with Promus element stent implantation; Procedure: IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion

• Registration Number: NCT01979744
• Lead Sponsor: Yonsei University

Brief Summary

Although first generation DES reduced instent restenosis, still remained the unsolved problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had been developed to improve the biocompatibility of stent coating focused on polymer compared to first generation DES, so that second generation stents showed better outcomes compared with first generation DES. On the other hands, in third generation DES, further refinement of DES involved more flexible stent platform. Promus ElementTM (Everolimus eluting stent, Boston Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting stent, Medtronic Vascular, Santa Rosa, CA) are the third generation drug eluting stents which are designed to increase flexibility. In previous randomized controlled studies, both of these stents have shown at least non-inferior angiographic and clinical outcomes compared to second generation DES. However, there is lack of data about comparison of angiographic and clinical outcomes between Promus ElementTM and Resolute Integrity®.

IVUS is one of the widely used intracoronary imaging devices to provide more reproducible and accurate information about coronary anatomy than angiography in current practice.8 Optimal stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an important factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been many studies to evaluate the procedural or clinical benefit of IVUS guided angioplasty. However, The clinical benefit of IVUS-guided angioplasty with stent implantation is still in a controversy. In the previous studies, IVUS-guided stent implantation showed positive or negative beneficial effect on clinical outcomes according to their study subjects. However, the stents used in the previous studies are less useful in current practice of cardiology and there is lack of data of 3rd generation DES, which have different stent profiles and outcomes with their predecessors.

Thus we would perform a prospective randomized study in order to compare the efficacy of IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long coronary lesions would have better clinical outcomes compared with conventional angiography-guided strategy. We also intend to assess the clinical outcomes after Promus ElementTM and Resolute Integrity® implantation.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2017-12
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 568

Inclusion Criteria

• Patients ≥ 19 years old
• Coronary artery disease and lesions which are candidate for treatment with drug eluting stent according to current clinical practice guidelines
• PCI for lesion(s) which needs a stent of 26mm or more
• Reference diameter from 2.25 to 4.0mm

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Exclusion Criteria

• Restenosis lesion
• Reference vessel diameter < 2.25 mm or > 4.0mm
• Primary PCI for STEMI
• Contraindication to anti-platelet agents
• Treated with any DES within 3 months at other vessel
• Severe hepatic dysfunction (3 times normal reference values)
• Pregnant women or women with potential childbearing
• Life expectancy < 1 year

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resolute Integrity - Angio	Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion	Resolute Integrity - Angio arm
Promus - Angio	Angiography guided percutaneous coronary angioplasty with Promus element stent implantation	Promus - Angio arm
Resolute Integrity - IVUS	IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion	Resolute Integrity - IVUS arm
Promus - IVUS	Angiography guided percutaneous coronary angioplasty with Promus element stent implantation	Promus - IVUS arm

Primary Outcome Measures

Name	Time	Method
Efficacy of angiography or IVUS guided third generation stent implantation	1 year after implantation	MACEs including cardiovascular death, myocardial infarction, stent thrombosis, and target vessel revascularization

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of